DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/17/2025.
Applicant’s election without traverse of Group I, claims 1-13 in the reply filed on 10/17/2025 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "an inner surface of a wall of a container unit" in line 5. It is unclear if this is the same inner surface as recited in claim 9 and the same container unit as recited in Claim 1. For examination purposes it is treated as the inner surface of a wall of the container body. Further clarification is requested.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chaves Fontes et al. (WO2017044861) in view of Czajka, Jr et al. (US20110030702A1).
Regarding Claim 1, Chaves Fontes teaches the following:
A chamber 102 (container) that is open at the top (opening) and can accommodate an organ (page 10)(an apparatus for storing an organ comprising a container unit comprising a container body defining a storage region for storing an organ or body tissue, wherein the container body includes an opening to enable the organ or body tissues to be admitted to, and removed from, the storage region through the opening)
Chaves Fontes further teaches a sterile drape which is attached to a lid covering the opening (page 10). Chaves Fontes does not teach the drape to include a securing portion which is securable to the container unit, a peripheral outer portion which surrounds the securing portion, and a frangible portion separating the securing portion from the peripheral outer portion, wherein the securing portion is securable to the container body to enable the drape to extend around a portion of the periphery of the opening with the peripheral outer portion of the drape arranged outward of the opening and wherein the frangible portion extends around the securing portion to enable the peripheral outer portion to be separated from the securing portion by tearing the frangible portion.
Czajka Jr. teaches a medical drape that comprises a base portion and an removably attached insert drape portion (Abstract). Czajka Jr. further teaches an insert drape portion 102 (securing portion), a base drape portion 101 (peripheral outer portion which surrounds the securing portion), and the base drape portion 101 is perforated adjacent to the securement area (frangible portion separating the securing portion from the peripheral outer portion)(para 35, 53, and Fig. 1, below). Czajka Jr. further teaches the drape would extend around the periphery of the opening with the peripheral outer portion of the drape arranged outward of the opening and wherein the frangible portion extends around the securing portion to enable the peripheral outer portion to be separated from the securing portion by tearing the frangible portion (Fig. 1, below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the organ container as taught by Chaves Fontes with the surgical drape as taught by Czajka Jr.
One would have been motivated to make this modification as it would allow for at least the base drape portion to be disposed of in traditional garbage sources and not in costly bio-hazard waste containers (para 56).
Regarding Claim 2, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 1 (see above). Chaves Fontes further teaches the container to have an attachment portion to which the surgical drape is securable (Fig. 1, below).
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Regarding Claim 3, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 2 (see above). Chaves Fontes further teaches the chamber 102 is open at the top (page 10) and therefore the attachment portion (the top of the container surrounding the opening) surrounds at least a portion of the opening of the container unit (see Chaves Fontes Fig. 1, above).
Regarding Claim 4, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 1 (see above). Czajka Jr. further teaches a procedural site 106 of the insert drape portion (securing portion) which has an adhesive 310 to secure the site to the patient (or container) and the adhesive is adjacent to the procedural site perimeter (para 58).
Regarding Claim 5, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 1 (see above). Czajka Jr. further teaches the drape to have the procedural site 106 (access opening) which would correspond to the opening of the container unit to enable the surgical drape to be secured to the container unit (para 58 and Czajka Jr. Fig. 1, above).
Regarding Claim 6, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 4 (see above). Czajka Jr. further teaches the drape to have the procedural site 106 (access opening) which would correspond to the opening of the container unit to enable the surgical drape to be secured to the container unit and the adhesive is adjacent to the procedural site perimeter (adhesive surrounds the access opening)(para 58 and Czajka Jr. Fig. 1, above).
Regarding Claim 7, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 1 (see above). Chaves in view of Czajka Jr further teaches a first surgical drape with a securing portion which is securable to the container body which enables the drape to extend around a portion of the periphery of the opening (see Claim 1 rejection, above). While Chaves Fontes in view of Czajka Jr. does not teach a second surgical drape comprising a second portion securing which is securable to the container body which enables the second drape to extend around a portion of the periphery of the opening, a duplication of parts has been held to be prima facie obvious and has no patentable significance unless new and unexpected results are produced. See MPEP 2144.04(VI)(B).
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chaves Fontes et al. (WO2017044861) in view of Czajka, Jr et al. (US20110030702A1) and further in view of Kravitz et al. (US20140017657A1).
Regarding Claim 8, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 7 (see above). Chaves Fontes in view of Czajka Jr. does not teach the container unit to comprise a second attachment portion to which the second surgical drape is securable.
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Kravitz teaches an apparatus for storage, treatment, and assessment of an organ in a perfusion circuit (Abstract). Kravitz further teaches the container to have a second attachment portion for a surgical drape (see Fig. 3, below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the organ container design as taught by Kravitz with multiple attachment portions to modify the device of Chaves Fontes in view of Czajka Jr. One would have been motivated to make this modification as it would have resulted in an effective organ container for the perfusion of an organ. Further, it is prima facie obvious that the selection of this design is known based on its suitability for containing and perfusing an organ. See MPEP 2144.07.
Regarding Claim 9, Chaves Fontes in view of Czajka Jr. and further in view of Kravitz teaches all of the limitations of Claim 8 (see above). Kravitz further teaches the second attachment portion comprises an inner surface of a wall of the container body (see Fig. 3, above).
Regarding Claim 10, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 1 (see above). Chaves Fontes in view of Czajka Jr. does not teach the container to comprise an inner lid member configured to secure the container body to enclose the organ within the storage region between the container body and the inner lid member.
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Kravtiz teaches a container body with an inner lid member which secures the container body to enclose the organ within the storage region (Fig. 3, below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chaves Fontes in view of Czajka Jr. to have an inner container and inner lid as taught by Kravitz. One would have been motivated to make this modification as it would have resulted in an effective organ container for the perfusion of an organ. Further, it is prima facie obvious that the selection of this design is known based on its suitability for containing and perfusing an organ. See MPEP 2144.07.
Regarding Claim 11, Chaves Fontes in view of Czajka Jr. and further in view of Kravitz teaches all of the limitations of Claim 9 (see above). Kravtiz further teaches a container body with an inner lid member which secures the container body to enclose the organ within the storage region (Fig. 3, above) and the second attachment portion comprises an inner surface of a wall of the container body which is external to the storage region enclosed by the lid member and the container body (Fig. 3, above).
Regarding Claim 12, Chaves Fontes in view of Czajka Jr. teaches all of the limitations of Claim 7 (see above). Chaves Fontes in view of Czajka Jr. does not teach the container to comprise an inner lid member configured to secure the container body to enclose the organ within the storage region between the container body and the inner lid member.
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Kravtiz teaches a container body with an inner lid member which secures the container body to enclose the organ within the storage region (Fig. 3, below). This configuration would enable the second drape to be secured to the container body so that a portion of the second drape overlies the inner lid member.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chaves Fontes in view of Czajka Jr. to have an inner container and inner lid as taught by Kravitz. One would have been motivated to make this modification as it would have resulted in an effective organ container for the perfusion of an organ. Further, it is prima facie obvious that the selection of this design is known based on its suitability for containing and perfusing an organ. See MPEP 2144.07.
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Regarding Claim 13, Chaves Fontes in view of Czajka Jr. and further in view of Kravitz teaches all of the limitations of Claim 10 (see above). Kravitz further teaches an outer lid member configured to be secured to the container body so as to enclose the inner lid member between the container body and the outer lid member (see Fig. 3, below).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796